FDA.reportPublic FDA data

Application 079112

Type
ANDA
Sponsor
WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
003FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
004FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo
006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-003FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08
A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-08a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDENUVICARE LLCdd0da52b-fc82-4ec9-854c-0d7c52e926fb2026-07-30WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
HIVES RELIEFFEXOFENADINE HYDROCHLORIDEWalgreen Companya79edb5d-02d9-4c53-9509-c69fd61156862026-07-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
equate allergy reliefFEXOFENADINE HYDROCHLORIDEWalmart Inc.852c8ad2-fc7d-4728-b2c6-f64b960fe2ab2026-07-18WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEBluePoint Laboratoriesa86aebd0-937e-5d73-e053-2995a90a656a2026-07-13WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Limited864e3052-5787-bf11-9d17-11274ca2304f2026-07-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.b0121213-eae1-8429-9986-3b3b26f35e472026-07-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS PHARMACYc77ee2bb-dc95-d8c9-e053-2995a90a96022026-07-08WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens AllergyFEXOFENADINE HYDROCHLORIDEH2-Pharma, LLC84988f6d-85b1-45dd-89be-0333acc6b1802026-06-25WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs58193632-2468-4159-b1a9-c24a489f199f2026-06-24WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Gencare-Allergy ReliefFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCa8595b29-1ea3-44aa-b131-030f34f408fc2026-06-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Ltd3151bc6d-b40b-4200-a5cf-e57b6791d92a2026-06-15WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limitede0537b71-fdee-4122-9c09-868ce73520802026-06-15WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEYYBA Corp53fe8ef5-ab65-f23e-e063-6394a90a30f02026-06-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEYYBA Corp53e87aa4-9db3-9ded-e063-6294a90a319e2026-06-10WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy 24 hourFEXOFENADINE HYDROCHLORIDESelect Consumer Group2de81a41-8488-7e39-e063-6294a90a394b2026-06-01WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEGrocery Outlet, Inc.441ce66e-515a-d380-e063-6394a90aec7d2026-05-21WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDENUVICARE LLC895de6e9-c5b6-42fe-b450-f5d8331ce2e32026-05-21WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEOHM LABORATORIES INC.1a1afa95-570d-456e-b436-a0fcfaf685172026-05-05WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy, Travel BASIXFEXOFENADINE HYDROCHLORIDELil' Drug Store Products, Incb82d993a-16ff-4037-a182-7010de8e1cdd2026-04-27WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11673-104Allergy ReliefFexofenadine HClTARGET CorporationANDACurrent
11673-104Allergy ReliefFexofenadine HClTARGET CorporationANDACurrent
11673-104Allergy ReliefFexofenadine HClTARGET CorporationANDACurrent
37012-189Fexofenadine HClFexofenadine HClShopko Stores Operating Co., LLC.ANDACurrent
53187-18924 Hour AllergyFexofenadine HClLIVE BETTER (The Great Atlantic & Pacific Tea Company)ANDACurrent
55648-744FexofenadineFexofenadineWockhardt LimitedANDACurrent
55648-982FexofenadineFexofenadineWockhardt LimitedANDACurrent
55648-987FexofenadineFexofenadineWockhardt LimitedANDACurrent
59726-189Allergy ReliefFexofenadine HClP and L Development of New York CorporationANDACurrent
59726-504Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-504Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-504Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
61715-049Fexofenadine HClFexofenadine HClPreferred Plus (Kinray)ANDACurrent
61715-049Fexofenadine HClFexofenadine HClPreferred Plus (Kinray)ANDACurrent
63868-024Fexofenadine HClFexofenadine HClChain Drug Marketing AssociationANDACurrent
63868-141Fexofenadine HClFexofenadine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-141Fexofenadine HClFexofenadine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63941-189Fexofenadine HClFexofenadine HClValu Merchandisers Company (Best Choice)ANDACurrent
63941-504Allergy ReliefFexofenadine HClBest Choice (Valu Merchandisers Company)ANDACurrent
63941-504Allergy ReliefFexofenadine HClBest Choice (Valu Merchandisers Company)ANDACurrent
63941-504Allergy ReliefFexofenadine HClBest Choice (Valu Merchandisers Company)ANDACurrent
64679-744ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-744ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-744ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-744ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-744FexofenadineFexofenadineWockhardt USA LLC.ANDACurrent
64679-744ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-982ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-982ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-982ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-982ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-982FexofenadineFexofenadineWockhardt USA LLC.ANDACurrent
64679-982ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-987ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-987ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-987ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-987ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-987FexofenadineFexofenadineWockhardt USA LLC.ANDACurrent
64679-987ALLERGY 24-HRFEXOFENADINE HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
68016-119Fexofenadine HClFexofenadine HClChain Drug Consortium, LLCANDACurrent
69842-704Allergy ReliefFexofenadine HClCVS PharmacyANDACurrent
69842-704Allergy ReliefFexofenadine HClCVS PharmacyANDACurrent
69842-704Allergy ReliefFexofenadine HClCVS PharmacyANDACurrent
71141-139Allergy ReliefFexofenadine HClLidl US, LLCANDACurrent
71141-139Allergy ReliefFexofenadine HClLidl US, LLCANDACurrent